Toxicologist @ American Engineering

Job Description

Job description
This position has the responsibility and authority to coordinate studies providing documented scientific support, and direction for biological evaluation of medical devices and materials. The toxicologist will establish and maintain a biological evaluation program that integrates risk management. The position provides technical guidance to engineers and/or project management during the design process to ensure material selection and device configurations that are biologically safe for use. The toxicologist interacts with cross-functional members from R&D, Manufacturing, Purchasing, Planning, Quality Assurance, and Regulatory Affairs during product development activities. The toxicologist will improve the biological evaluation process using databases, information systems, and training programs.
POSITION RESPONSIBILITIES:
Responsibilities may include the following and other duties may be assigned.
Provide biological safety assessment to achieve ISO 10993 compliance and to support product development activities.
Provide guidance in the development of products and selection of materials to ensure that released designs meet biological safety requirements. The Toxicologist is responsible for the timely completion of technical deliverables.
Prepares documentation of biological assessment efforts using sound scientific principles. Coordinates biological testing activities by partnering with MDT Physiological Research Laboratories as appropriate. Is the primary interface between MDT and external/internal service providers.
Establishes and integrates risk management process as part of the biological evaluation program in a manner that complies with ISO 10993
Assesses the biological safety impact of manufacturing and supplier changes on patient-contacting devices.
Consults on the biological safety impact of device field issues.
Develops or identifies resources and provides training to aid product development activities with biological evaluation process (web-based biomaterials support, biomaterials testing databases).
Mentors engineers.

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Keyskills:   toxicology toxicologic pathology clinical toxicology medical toxicology occupational medicine medical devices analytical skills